Alzheimer's disease is a neurodegenerative disease that, in its most common form, is found in people over age 65. Approximately 15 million people worldwide have Alzheimer's disease.
Clinical signs of Alzheimer's disease are characterized by progressive cognitive deterioration, together with declining activities associated with daily living and by neuropsychiatric symptoms or behavioral changes.
Alzheimer's disease is characterized by the accumulation of plaque in brain tissues that is composed of β amyloid peptides. Administration of anti-β amyloid-antibodies to a mouse model of Alzheimer's disease appears to reduce β amyloid deposits in the mouse brain and restore or increase cognitive function or at least the rate of cognitive decline.
Naturally-occurring antibodies against β amyloid peptides are present in human serum. Administration of human immunoglobulin preparations obtained from human serum into humans is associated with a decrease in β amyloid-peptide levels in the cerebrospinal fluid. [US2002/0009445.] Recent clinical trial data shows beneficial outcomes in both behaviour and cognition in Alzheimer's disease patients treated with intravenous immunoglobulin (“IVIg”) (www.news-medical.net/?id=40383).
However, such IVIg preparations contain significant amounts of neurotoxic β amyloid peptides and exhibit significant variation in antibody affinity and titre.